Validation Engineering Tech

Validation Consultant
About the Job Validation Consultant
We are seeking an experienced, motivated, and detail-oriented Validation Consultant Computer Systems to join our on-site team in Wichita, specializing in applying risk-based validation practices for computerized systems (CSA/CSV) in a regulated environment. The ideal candidate will have a formal understanding of relevant enterprise class IT/OT systems and technology and a keen interest in quality and regulatory operations in the life sciences industry, including pharmaceuticals, biotechnology, and healthcare.
This role entails validating production, enterprise systems, infrastructure, and laboratory equipment to ensure sustained quality and compliance. As a Validation Consultant you will be responsible for the SDLC and validation execution in client environments to ensure their compliance, particularly in regulated industries such as pharmaceuticals. You will be executing rigorous and risk-based validation protocols, developing test strategies, and managing documentation for system functionality, data integrity, and compliance. We are looking for people with both technical aptitude and the ability to think critically and analyze not just the technology but the people and the processes that surround it as well. You’ll be solving technical problems and providing best-in-class solutions to our clients and users to maximize the value of technology in their business.
Our company serves clients from growth startups to the Fortune 50 within Life Sciences and Healthcare.
Work on-site at our offices or client offices or facilities on a daily basis
Develop, execute, and document validation protocols (IQ/OQ/PQ) for computerized systems
Conduct validation testing, assess test results, and ensure compliance with regulatory standards
Conduct risk assessments and develop mitigation plans to ensure data integrity
Collaborate with Engineering/Automation, IT, QA, Production, and laboratory teams during system implementation or system upgrades
Review systems to ensure they meet validation and regulatory compliance requirements
Verify system functionality, reporting, compliance, security & access controls, data/system backup, etc
Understand client requirements, business objectives & processes, in addition to their technology and systems
Leverage your sales mindset to deepen customer relationships, help transform services into comprehensive solutions, and collaborate with the sales team to align goals with outcomes
Identify expansion opportunities to drive growth and ensure customer satisfaction through innovative IT/OT validation strategies
Provide strategic advice on using technology to achieve goals using an understanding of the Oversee or support the implementation of IT/OT solutions tailored to the life sciences sector, including but not limited to laboratory information management systems (LIMS), manufacturing execution systems (MES), manufacturing/filling lines, and enterprise resource planning (ERP) systems from the validation perspective
Understand and develop SDLC and technical validation documentation and execute testing where appropriate
Work collaboratively with cross-functional teams, including R&D, quality assurance, and manufacturing, to deliver IT/OT solutions that meet business needs
Bachelors (BSc/BA) degree in Information Technology, Computer Science, Engineering, or a related field. MSc/MBA in business will be a plus

• 1-8 years of experience in Computer Systems Validation, preferably within the life sciences industry
• Experience with computerized system validation, documentation practices, and data integrity compliance
• Strong understanding of validation requirements for computer systems validation/computer software assurance in a GMP, GLP, or GCP environment
• Proficiency with validation lifecycle documents, risk management, and software development lifecycle (SDLC)
• Knowledge of applicable regulatory standards (e.g., A high degree of proficiency with Microsoft Word and Microsoft Excel
• Employees will be expected to commute up to 70 miles each way per day to various client sites if working at a long-term client facility. BYOD is expected, employees will be required to use a cell phone for work purposes including the installation of work communication tools such as MS Teams or Outlook

Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience

• Knowledge of enterprise IT systems, including systems such as Active Directory, IAM, ERP, and Operational Technology systems, including but not limited to experience with IIoT, PLCs, HMIs, SCADAs, etc.
• Required Citizenship / Work Permit / Visa Status: currently authorized to work in the United States

Must-Haves Minimum Qualifications: Bachelors (BSc/BA) degree in Information Technology, Computer Science, 4-8 years of experience in Computer Systems Validation, preferably within the life sciences industry Experience with computerized system validation, documentation practices, and data integrity compliance. Strong understanding of validation requirements for computer systems validation/computer software assurance in a GMP/GLP/GCP environment. Proficiency with validation lifecycle documents, risk management, and software development lifecycle (SDLC) Experience of applicable regulatory standards.